FDA Drug Listing Certificate Services
We prepare a professional verification certificate that summarizes applicable FDA drug establishment registration and drug listing information for business partners, distributors, due diligence, and regulatory records.
What Is an FDA Drug Listing Certificate?
An FDA Drug Listing Certificate, as offered by FDA Registration Assistance, is an informational verification document prepared from applicable FDA drug registration and listing records. It can help a company present its current registration and listing information clearly to customers, distributors, importers, tender teams, or other business partners.
Applicable establishment registration information, drug listing/NDC data, and the date the records were reviewed.
FDA product approval, FDA endorsement, import clearance, reimbursement eligibility, or compliance with every requirement.
FDA listing publications contain information submitted to FDA and should not be represented as proof that FDA verified or approved the product.
We can scope the certificate to a specific establishment, product portfolio, listing set, or group of NDCs.
What Our Drug Listing Certificate Service Includes
A focused verification workflow designed to create clear documentation without implying FDA approval or issuance.
Eligibility & Record Review
We identify the establishment and drug listing records relevant to your request and flag missing, inactive, or inconsistent information before certificate preparation.
Registration & Listing Verification
We review applicable current FDA drug-establishment registration information and drug listing/NDC data based on the requested scope.
Professional Certificate Preparation
We prepare a professional document that summarizes the records checked, the relevant registration/listing details, and the verification date.
Disclosure & Presentation Guidance
We provide the certificate with clear language explaining that it is prepared by FDA Registration Assistance and is not an FDA approval certificate.
Drug Registration & Listing Facts That Matter
A certificate is only as useful as the registration and listing records behind it.
Our 4-Step Certificate Verification Process
A straightforward process from record identification to final documentation.
Send Your Details
Provide your company or establishment name and the drug products, listings, or NDCs you want covered.
Records Are Checked
We review the applicable FDA establishment-registration and drug-listing sources for the requested scope.
Certificate Is Prepared
We prepare the verification document with the relevant information and a clear non-approval disclosure.
Delivery & Support
You receive the completed certificate and can ask questions about appropriate use with partners or internal teams.
FDA Drug Listing Certificate FAQs
Clear answers about certificate scope, FDA listing status, NDCs, renewal, and what the document does—and does not—represent.
What is an FDA Drug Listing Certificate?
An FDA Drug Listing Certificate from FDA Registration Assistance is a professional verification document that summarizes drug establishment registration and drug listing information found in applicable FDA records. It is prepared by FDA Registration Assistance for business, due-diligence, distributor, and internal compliance purposes; it is not a certificate issued by FDA.
Does FDA issue or approve Drug Listing Certificates?
No. FDA drug establishment registration, drug listing, and NDC assignment do not by themselves mean that FDA has approved a company or product. The certificate offered on this page is prepared by FDA Registration Assistance from available FDA registration and listing records and must not be represented as an FDA approval certificate.
Who can request a Drug Listing Certificate?
Companies with drug registration and listing information that can be verified in applicable FDA records may request a certificate. If a required registration or listing is missing, inactive, outdated, or incomplete, FDA Registration Assistance can identify the issue and discuss the filing work needed before certificate preparation.
What information can be included on the certificate?
Depending on the verified records and requested scope, the certificate may summarize the company or establishment name, current establishment-registration information, labeler information, listed drug products, NDC information, and the date on which the underlying FDA records were checked.
Is a Drug Listing Certificate proof that a drug is FDA-approved?
No. Drug establishment registration, inclusion in FDA listing publications, and possession of an NDC do not denote FDA approval. The certificate is informational and should never be used to imply that FDA has approved a facility or drug merely because it is registered or listed.
Why do distributors or business partners ask for a certificate?
A distributor, importer, customer, tender team, marketplace, or business partner may want a concise document showing the registration and listing information that was verified for a company or product. The certificate can make due diligence easier, but it does not replace any FDA filing, approval, import, or compliance requirement.
How do you verify the FDA records?
FDA Registration Assistance reviews applicable FDA registration and listing sources, such as current drug-establishment registration information and drug listing/NDC data, based on the certificate scope. FDA public listing information reflects data submitted to FDA and should not be interpreted as FDA product approval.
How long does certificate preparation take?
Our typical service target is 3–5 business days after we receive the information needed to identify the establishment and drug listings and can verify the applicable FDA records. Complex portfolios, record discrepancies, or inactive listings may require additional time.
How much does an FDA Drug Listing Certificate cost?
This service is custom quoted. Pricing depends on the number of products, NDCs, establishments, and the verification scope required. Send us your company and listing details and we will confirm the professional service fee before proceeding.
Can foreign drug companies request a certificate?
Yes. FDA Registration Assistance can prepare verification certificates for eligible foreign drug companies as well as domestic companies when the relevant registration and listing information can be confirmed. Foreign establishments may also need a U.S. Agent as part of their FDA establishment registration obligations.
Do I need an active drug establishment registration first?
If the certificate is intended to confirm establishment registration, that registration should be current. Drug establishments that are required to register must renew their registration annually between October 1 and December 31. If your registration is not current, we can assist with renewal before preparing updated verification documentation.
Do drug listings have to be kept current?
Yes. FDA requires drug listing information to be updated when changes occur, with applicable updates due no later than the following June or December. For listings with no changes during the calendar year, an annual no-change certification may be submitted between October 1 and December 31.
What happens if a drug listing is not annually certified?
FDA states that human drug listings requiring certification may be inactivated if they are not certified during the October 1–December 31 renewal period. Inactivated listings can be removed from the NDC Directory and other FDA publications of listing data.
Does an NDC number mean FDA approved the product?
No. FDA expressly states that assignment of an NDC number does not denote FDA approval. The NDC is an identifier used in drug listing, and any certificate that references an NDC should be presented only as verification of listing information—not as evidence of product approval.
Can the certificate be used for import or export documentation?
It may be useful as supporting business documentation when a distributor, foreign authority, customs intermediary, or trading partner asks for evidence of FDA registration or listing information. Acceptance depends on the requesting party, and the certificate is not an FDA import clearance, export certificate, or product approval.
Can you help if our registration or listing is not current?
Yes. FDA Registration Assistance can help with drug establishment registration, annual renewal, Labeler Code requests, NDC/product listing work, DUNS assistance, U.S. Agent services, and related drug compliance filings before preparing updated certificate documentation.
Request Your Drug Listing Verification Certificate
Send us the company and product details you want verified. We’ll confirm the scope, eligibility, turnaround, and custom professional fee.
Request Received
Thank you. We’ll review the requested verification scope and contact you with the next steps.